MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years
• Males and females 18-65 years of age.
• Isolated ileocolic Crohn's disease of \<30 cm in length
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Medically refractory disease or inability to tolerate ongoing medical therapy